Medical Device Software Development Plan
Organize medical device software lifecycle planning with this editable Medical Device Software Development Plan, written to address IEC 62304:2006 including Amendment 1:2015. Supplied as one editable Microsoft Word document in a digital download.
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Software lifecycle activities and responsibilities
Organize medical device software lifecycle activities with this editable Software Development Plan document. It guides phases and responsibilities, requirements, design, traceability, configuration and risk management, and maintenance while addressing IEC 62304:2006 including Amendment 1:2015 and related software lifecycle guidance.
The Software Development Plan addresses content contained within IEC 62304:2006 including Amendment 1:2015, ISO/IEC/IEEE 12207:2026 and FDA Guidance. The Medical Device Software Development Plan helps the user to organize the necessary roadmap, phases and tasks required throughout the development lifecycle, regardless of which life cycle model or approach is employed.
Software definition, requirements and design specification
Development phases, roles and traceability
Configuration management, risk management and software maintenance
Standards and frameworks addressed: IEC 62304:2006 including Amendment 1:2015; ISO 13485:2016; FDA QMSR.
For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.
For the wider SaMD development process, see the SaMD Development Procedure. For clinical evidence supporting software claims, see the Software Clinical Evaluation Procedure.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Software: Development, Validation and Clinical Evidence for workflow guidance, a checklist and common mistakes.
Part of a procedure bundle
This document is also included in Medical Device Software Procedure Bundle. Explore the bundle for the related documents.
Software Development Plan vs SaMD Procedure vs Software Bundle
